US FDA Registration for Food, Cosmetics and Devices

Almost every consignment of food, cosmetics or medical devices leaving India for the United States passes an FDA check before it reaches the buyer. The FDA is not inspecting quality at the port; it is checking whether your facility is on its register, whether the shipment was declared in advance, and whether the label says what US law requires. This guide sets out what to file on each track, what it costs, and what causes refusal.

First principle: registration is not approval

The FDA registers facilities and lists products. For ordinary food and cosmetics it does not review, approve or certify what you make before it enters the country. Registration only tells the agency that your premises exist, what you produce and who to contact. There is no certificate and no approval number.

This matters commercially, because so many Indian exporters print "FDA Approved" on a website or carton. The FDA's position is blunt: a database entry "does not denote approval, clearance, or authorization", and a firm displaying a registration certificate to imply FDA review is misbranding the product in violation of the Federal Food, Drug, and Cosmetic Act. The "FDA Registration Certificates" sold by consultants are commercial documents, not government ones. The only defensible claims are "FDA-registered facility", "510(k) cleared" (if it is), or "FDA approved" (only for a device with a PMA).

The three tracks at a glance

Note the fee asymmetry. Food and cosmetic registration are free; devices carry a rising annual establishment fee — USD 11,423 in FY2026, USD 13,785 in FY2027 — payable by every registered establishment, with no small-business reduction on it. Treat it as a fixed cost of market access. Separately, factor the 18% reciprocal tariff on Indian-origin goods in force since February 2026 into landed cost; there is no India-US FTA, and quoting DDP without it is an expensive error — see Incoterms 2020.

The US Agent

Every foreign facility on all three tracks must name a US Agent — a person or business with a physical US address acting as the FDA's contact point. The agent is not your importer and does not assume your liability. Exporters routinely nominate their first US customer; when that relationship ends, FDA correspondence, including a detention notice, goes to someone with no interest in answering it. Appoint an independent agent.

Food

Registration under the Bioterrorism Act, as expanded by FSMA, applies to any facility that manufactures, processes, packs or holds food for US consumption; farms and most retail are excluded. It is electronic and free, and requires a unique facility identifier (the FDA accepts a DUNS number) plus your consent to FDA inspection.

Prior Notice is a separate filing for every shipment, not a one-time registration. It must reach the FDA no more than 15 calendar days before arrival, and no less than 2 hours before arrival by road, 4 hours by air or rail and 8 hours by water, carrying the manufacturing facility's registration number. Missing or inadequate Prior Notice is itself grounds for refusal.

FSVP — the Foreign Supplier Verification Program — is a duty on the US importer, not on you, but the importer discharges it using documents you supply: hazard analysis, food safety plan, audit reports, test results. A buyer who cannot build an FSVP file around your factory will not reorder.

Preventive Controls under 21 CFR 117 require a written food safety plan — hazard analysis, controls, monitoring, corrective actions, verification — prepared or overseen by a Preventive Controls Qualified Individual with recognised training. A PCQI on the payroll shortens buyer due diligence.

Acidified and low-acid canned foods carry an extra layer that constantly catches out pickle, chutney and curry paste exporters. A commercial processor must obtain a Food Canning Establishment number and file each scheduled process before shipping — Form FDA 2541 for the establishment, 2541e for acidified processes, 2541d/f/g for low-acid ones — the process itself developed by a qualified process authority. This is separate from food facility registration, and shipping without a filed process is a routine cause of detention. Your FSSAI export licence substitutes for none of it.

Cosmetics under MoCRA

MoCRA ended the era in which cosmetics reached the US with almost no federal filing. Facilities processing cosmetics for the US market must register, and the Responsible Person — the manufacturer, packer or distributor named on the label — must list every marketed product with its ingredients. Filing is free, through Cosmetics Direct or on Forms FDA 5066 and 5067. Facility registration renews every two years from your own registration date; listings are updated annually.

Three obligations sit alongside the filings. Safety substantiation: the Responsible Person must hold records adequately substantiating safety. MoCRA prescribes no specific tests but expects a defensible dossier — much the same evidence base as an EU CPNP notification, so build one file for both markets. Serious adverse event reporting within 15 business days, with follow-up for a year. And records access: the FDA may demand and copy safety records, and holds mandatory recall authority.

Small businesses below the statutory revenue threshold are exempt from registration and listing — but not for products that contact mucous membranes, are injected, are for internal use, or alter appearance for more than 24 hours.

Rulemaking remains pending on cosmetic GMP, fragrance allergen labelling, and test methods for asbestos in talc products (proposed, not final as of August 2026). None are enforceable yet, but all three are coming: capture fragrance allergen data and talc supplier test certificates now.

Devices

A foreign establishment making a device for the US market must register annually under 21 CFR 807, list each device, name a US Agent and identify a US initial importer. Registration is not marketing authorisation. Most Class II devices need a 510(k) clearance showing substantial equivalence to a legally marketed predicate; the FY2027 standard fee is USD 28,653, reduced to USD 7,163 under the Small Business Determination programme. Many Class I devices are 510(k)-exempt, but that exempts you from nothing else: registration, listing, labelling and quality system requirements still apply. Most devices also need a Unique Device Identifier on label and packaging from an accredited issuing agency, with the record submitted to GUDID.

What happens at the port

Entry data goes to CBP electronically and is screened by FDA systems; a clean entry with complete, accurate data can be released without human review. Anything that flags — a mismatched registration number, an unfamiliar product code, a firm with history — goes to a reviewer, who may request documents, examine or sample.

If the product appears to violate the Act, the FDA issues a Notice of Detention and Hearing. You then have a defined window — generally 10 business days from detention, often stated as 20 calendar days to allow for post — to submit testimony: private laboratory results, corrected labels, documentation, or an application to recondition on Form FDA 766. If nothing arrives by the deadline, a refusal of admission issues, and you have 90 days to export or destroy under CBP supervision. Detention is answerable; silence is fatal.

Import Alerts

An Import Alert places a firm, country or commodity on detention without physical examination (DWPE). Once on the "red list", every shipment is detained on arrival and you carry the burden of proving each consignment compliant, usually through third-party laboratory analysis at your cost. Indian exporters land on alerts most often for pesticide residues, aflatoxin, Salmonella, unapproved colours, undeclared allergens and insanitary conditions.

Getting off is a petition, not an appeal: an investigation showing how the violation occurred, the corrective actions taken, the measures stopping recurrence, and evidence they work. The FDA weighs the totality of evidence; petitioners are in practice expected to show a run of consecutive compliant shipments — five is commonly cited — with independent laboratory results and often a third-party audit. Expect months, not weeks.

Labelling and the mistakes that cause refusal

Labelling causes more refusals than anything else, because it is what a reviewer can check from the desk. Food under 21 CFR 101 needs a statement of identity, net quantity in both US customary and metric units, an ingredient list in descending order of predominance, the manufacturer, packer or distributor's name and address, and a Nutrition Facts panel in the current format — with "Added Sugars", updated serving sizes and mandatory vitamin D and potassium declarations. All nine major food allergens must be declared, sesame having been added by the FASTER Act, and everything must be in English. Cosmetics need an ingredient declaration, net contents and the Responsible Person's details. On all three tracks, any claim that a product treats or prevents disease turns it into a drug with a far more expensive pathway — the commonest own goal in the ayurvedic and nutraceutical segments.

• Letting the biennial food facility registration lapse, then discovering it when Prior Notice is rejected.
• Using a customer or forwarder as US Agent and losing FDA correspondence when that relationship changes.
• Shipping acidified or low-acid canned product without an FCE number and filed scheduled process.
• Claiming "FDA Approved", or displaying a purchased registration certificate.
• Indian-format labels: metric-only net contents, no Nutrition Facts panel, missing allergen statement, therapeutic claims.
• Ignoring a detention notice until the response window has closed.
• Declaring a product code that contradicts the label — check it against your HS code classification first.

Where OZIANT and ZJELL fit

OZIANT is a B2B cross-border marketplace connecting overseas buyers with Indian suppliers, and US buyers routinely ask for registration status before they ask for a price. ZJELL Limited, the group's export consulting arm, handles food facility registration and renewal, MoCRA filings, device registration and listing, US Agent appointment and label review. If you are preparing a first US shipment or facing the 31-12-2026 deadline, contact the team.